- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03295838
Outcomes of Mentalization-Based Treatment for Borderline Personality Disorder
September 25, 2017 updated by: Viktor Kaldo, Karolinska Institutet
Symptom, Alexithymia and Self-image Outcomes of Mentalization-Based Treatment for Borderline Personality Disorder: a Naturalistic Study
The effects of a psychological treatment, Mentalization-Based Treatment, was studied using a research protocol with patients with mood swings and impulsive behavior (borderline personality disorder).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Background: Mentalization-based treatment (MBT) in borderline personality disorder (BPD) has a growing evidence base, but there is a lack of effectiveness and moderator studies.
The present study examined the effectiveness of MBT in a naturalistic setting and explored psychiatric and psychological moderators of outcome.
Method: Borderline and general psychiatric symptoms, suicidality, self-harm, alexithymia and self-image were measured in a group of BPD patients (n=75) receiving MBT; assessments were made at baseline, and subsequently after 6, 12 and 18 months (when treatment ended).
Borderline symptoms were the primary outcome variable.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- To be included, BPD diagnosis was confirmed by SCID-II interview and the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) interview, together with a consensus discussion between MBT therapists using DSM-IV and ICD-10 criteria. All patients referred between 2007-02-01 and 2012-05-30 were eligible for inclusion.
Exclusion Criteria:
- Exclusion criteria were: IQ<85, psychotic disorder other than schizotypal personality disorder, acute/temporary psychosis, previously diagnosed autism-spectrum disorder, bipolar disorder type I and severe eating or substance use disorder.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mentalization-based Treatment
MBT was conducted according to the treatment manual developed by Bateman & Fonagy.
Patients were offered individual sessions with a psychotherapist and group sessions with 6-8 participants and 1-2 group therapists for 18 months.
An introductory psycho-educational component (9-12 sessions) was also offered focusing on explicit mentalising skills (i.e.
understanding one's own or others' intentions).
Group and individual MBT focused on implicit mentalising towards self and others.
|
See Arm description
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Borderline Symptoms
Time Frame: 0-18 months
|
Key psychiatric and borderline symptomatology as measured by the Karolinska Borderline And Symptoms Scales (KABOSS-S) was the primary outcome measure.
The KABOSS-S consists of three general symptom scales (depression, anxiety, obsessive-compulsive symptoms) derived from the Comprehensive Psychopathological Self-rating Scale for Affective Syndromes and one specific borderline scale compromising the items "Mood swings", "Ability to understand own emotions", "Self-control", "Self-soothing", "Feelings of abandonment", "Feelings of emptiness", "Self-image" and "Reality Presence".
Each item is scored on a Likert scale from 0 ("no presence") to 6 ("severe").
|
0-18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Suicidality
Time Frame: 0-18 months
|
Suicidality was measured by the Suicide Assessment Scale, Self-Report (SUAS-S), which covers factors known to influence suicide risk, such as affect, bodily states, control and coping, emotional reactivity, as well as suicidal thoughts and behaviour.
|
0-18 months
|
|
General Psychiatric Symptoms
Time Frame: 0-18 months
|
General psychiatric symptoms were measured using the Symptom Checklist-90 Revised (SCL-90-R), an established instrument with well-known reliability and validity.
|
0-18 months
|
|
Self-harm
Time Frame: 0-18 months
|
Self-harm was measured by the Deliberate Self-Harm Inventory-9 (DSHI-9), which has well-known reliability and validity.
This measure was introduced halfway through the study period (N=42).
|
0-18 months
|
|
Alexithymia
Time Frame: 0-18 months
|
The Toronto Alexithymia Scale-20 (TAS-20) was used to measure alexithymia.
It comprises 20 items divided into three subscales: Difficulty Identifying Feelings, Difficulty Expressing Feelings and Externally Oriented Thinking.
TAS-20 was used to measure affective mentalization.
|
0-18 months
|
|
Self-image
Time Frame: 0-18 months
|
Self-image was assessed using Structural Analysis of Social Behavior (SASB).
SASB is based on a circumplex model, measuring self-image and interpersonal interactions in relation to three interpersonal "surfaces" (i.e.
actions of others, reactions to others and the introject, or what can be called the self-image.
The third surface (self-image) was used, which comprises eight clusters of self-image: 1) Autonomy; 2) Self-affirmation; 3) Active self-love; 4) Self-protection; 5) Self-control; 6) Self-blame; 7) Self-attack; and 8) Self-neglect.
|
0-18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Viktor Kaldo, PhD, Karolinska Institutet
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2007
Primary Completion (Actual)
May 3, 2014
Study Completion (Actual)
May 3, 2014
Study Registration Dates
First Submitted
September 14, 2017
First Submitted That Met QC Criteria
September 25, 2017
First Posted (Actual)
September 28, 2017
Study Record Updates
Last Update Posted (Actual)
September 28, 2017
Last Update Submitted That Met QC Criteria
September 25, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DNR 2011/1909-31/3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The dataset used and/or analysed during the current study are available from the corresponding author on reasonable request.
IPD Sharing Time Frame
1st feb 2007 - 3rd may 2014.
IPD Sharing Access Criteria
Upon reasonable request.
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
- Analytic Code
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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